Osteotech Completes Enrollment For DuraTech(TM) BioRegeneration Matrix Clinical Trial

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Jun 2009 - 4:00 PDT

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Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced that it has completed enrollment for the clinical trial of its DuraTech(TM) BioRegeneration Matrix. Based upon Osteotech's proprietary HCT(TM) (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.

DuraTech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results stemming from this trial to support its 510(k) filing for marketing clearance with the United States Food and Drug Administration later this year.

"The new dural substitute, DuraTech, provides a unique solution for surgeons," said Dr. Carl Bruce, Consultant Neurosurgeon at the University of the West Indies, who was one of the investigating surgeons participating in the clinical trial. Dr. Bruce continued, "DuraTech is strong enough to hold sutures, but at the same time handles easily and conforms to convexity, making it ideal for onlay grafts. This important combination is not present in many other products currently on the market." Dr. Oscar Aponte, Neurosurgeon, Professor of Rosario University and Dr. Mauricio Riveros Castillo, Chief of Neurosurgery, Samaritana University Hospital and Hospital Mayor, the two remaining surgeons participating in the clinical trial added, "DuraTech was easy to use, handled well and provided the flexibility needed for different surgical procedures quickly taking the shape of the underlying tissue."

DuraTech is the leading product in Osteotech's HCT platform, which is based on Osteotech's breakthrough and proprietary first-in-class biomaterial. DuraTech will provide surgeons with greater flexibility to cut, shape and suture the material to fit each patient's needs. Based on available data, Osteotech estimates that the annual market for dural repair substitutes is approximately $100 million.

In addition to DuraTech, which is expected to launch late this year, Osteotech plans to introduce additional tissue products based upon its HCT platform over the next several years that address patient needs and expand the addressable market for this innovative technology. These products include: rotator cuff repair, wound care applications and abdominal wall reconstruction; Osteotech estimates that this expanded addressable market opportunity will eventually be in excess of $1 billion yearly.

"We remain on track to file our 510(k) for DuraTech during the third quarter of 2009 and anticipate clearance of the product before the end of the year," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "We look forward to evaluating the results of the clinical trial and believe that the data will show that our first-in-class biomaterial stimulates the body's natural healing processes and helps reduce the potential for immune reactions. Our HCT platform will support a variety of new products currently in development and we are excited about its future. We believe the technology platform will yield safe and clinically effective regenerative healing products that can satisfy the emerging needs of surgeons and the patient communities they serve."

About DuraTech(TM) BioRegeneration Matrix

Utilizing Osteotech's HCT platform, DuraTech is an engineered nano-structure human collagen material that provides a porous scaffold to facilitate cellular in-growth and healing. The DuraTech BioRegeneration Matrix is the lead product in Osteotech's collagen platform and is designed to be utilized to repair the dura mater, a fibrous membrane that protects the brain and the spinal cord, when the dura mater has been compromised due to injury or surgery. Osteotech's proprietary collagen technology platform is supported by three pending patent applications.

About Osteotech

Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in providing biologic solutions for regenerative medicine to support surgeons and their patients in the repair of the musculoskeletal system through the development of innovative therapy-driven products that alleviate pain, promote biologic healing and restore function.

Certain statements made throughout this press release that are not historical facts contain forward-looking statements (as such are defined in the Private Securities Litigation Reform Act of 1995) regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company's ability to develop and introduce new products, differences in anticipated and actual product and service introduction dates, the ultimate success of those products in the marketplace, the continued acceptance and growth of current products and services, the impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. All information in this press release is as of June 10, 2009 and the Company does not intend to update this information.

Source: Osteotech, Inc